Phase II/III Trial of Hepatocellular Carcinoma Patients Treated by ex Vivo Expanded Autologous Immune Killer Cells as the Adjunct Therapy
Conditions
Hepatocellular Carcinoma - Liver Cancer
Conditions: official terms
Carcinoma - Carcinoma, Hepatocellular
Conditions: Keywords
hepatocellular carcinoma, HCC, NK, immune killer cells
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: immune killer cells (IKC)
Type: Biological
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in:

1. Reduction of tumor size

2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 79 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Sign and give written informed consent.

2. Age≧20 years, but<80 years.

3. Hepatocellular carcinoma by CT, MRI, AFP, angiography or cytology/biopsy examinations.

4. Barcelona staging system stage B and C.

5. Never receive TACE treatment and comply with the standard of TACE treatment.

6. Child-Pugh stage A and B.

7. ECOG performance status 0 to 2.

Exclusion Criteria:

1. Participant of other clinical trial within the past 4 weeks of screening period.

2. Receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.

3. Carriers of HIV or HTLV within the past 4 weeks of screening period.

4. With Active acute or chronic infection(by investigator's judgement).

5. Other diseases, except hepatocellular carcinoma, which are life-threatening to the patients(by investigator's judgement)for example:

5.1 Active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction.

5.2 With previous history of encephalopathy within the past six months. 5.3 Involved Involving systemically or known central nerve system diseases(brain or meningeal metastasis).

6. Women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.
Location
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Status: Recruiting
Contact: Hui Jiun Chen - 886966149672
Start Date
May 2009
Sponsors
Shin Kong Wu Ho-Su Memorial Hospital
Source
Shin Kong Wu Ho-Su Memorial Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page